510(k) K852847
- Device
- Sopheia Dhea-so4 Eia Kit
- Applicant
- DIAGNOSTIC PRODUCTS CORP.
- 510(k) number
- K852847
- Product code
- JKC
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1985-08-02
- Date received
- 1985-07-05
- Regulation
- 862.1245
- Classification name
- Radioimmunoassay, Dehydroepiandrosterone (Free And Sulfate)
- Medical specialty
- Clinical Chemistry
- Review panel
- Clinical Chemistry
- Device class
- 1
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Contact
- SIDNEY A AROESTY
- Address
- 5700 W. 96th St. Los Angeles CA US 90045 90045
FDA Registration Numbers#
- 2432235
- 3005333358
- 3006198300
- 3022178699
- 3009518015
- 3002806944
- 3011989923
- 8010132
- 3002800697
- 3002809144
- 3007361513
- 2029372
- 9610126
- 2245285
- 1036362
- 3007118747
- 3017019647
- 8031673
- 2020726
- 3003559191
- 2122870
- 3009335633
- 3014325803
- 3005542422
- 3005529799
- 9610746
- 9710337
- 9612316
- 1222302
- 2133982
- 3003741796
- 1219913
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code JKC#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K040181 | ACCESS DHEA-S REAGENT ASSAY | Beckman Coulter, Inc. | 2004-03-24 |
| K003174 | ELECSYS DHEA-S | Roche Diagnostics Corp. | 2001-01-17 |
| K973897 | DHEA-S | Kmi Diagnostics, Inc. | 1997-11-13 |
| K962895 | DSL DHEA-S-7 | Diagnostic Systems Laboratories, Inc. | 1996-09-10 |
| K955114 | DSL AACTIVE DHEA EIA KIT | Diagnostic Systems Laboratories, Inc. | 1996-02-23 |
| K950524 | NICHOLS INSTITUTE DIAGNOSTICS DHEA-S CHEMILUMINESCENCE IMMUNOASSAY | Nichols Institute | 1995-05-15 |
| K942051 | SR1 DHEA-S ENZYME IMMUNOASSAY | Serono Diagnostics, Inc. | 1994-07-13 |
| K935014 | ACTIVE DEHYDROEPIANDROSTERONE (DHEA)(DSL 9000) | Diagnostic Systems Laboratories, Inc. | 1994-05-09 |
| K935806 | IMMULITE DHEA-S04 | Diagnostic Products Corp. | 1994-04-26 |
| K935469 | SYNELISA DHEA-SULFATE | Elias U.S.A., Inc. | 1994-03-22 |
| K931601 | CHEMILUMINESCENCE DHEA-S IMMUNOASSAY | Nichols Institute | 1993-07-27 |
| K903616 | DSL ANDROSTANEDIOL GLUCURONIDE (DSL #6000) | Diagnostic Systems Laboratories, Inc. | 1990-09-10 |
| K891478 | DSL 7900 ACTIVE DHEA-S (DSL #7900) | Diagnostic Systems Laboratories, Inc. | 1989-04-26 |
| K872879 | DHEA-S RIA KIT | Endocrine Associates, Inc. | 1987-10-23 |
| K853867 | PANTEX DIRECT DHEA-S COATED TUBE RADIOIMMUNOASSAY | Pantex, Div. Bio-Analysis, Inc. | 1985-10-04 |